Nasal Cancer |
Nasal Cavity and Paranasal Sinus Cancer; Nasal Cavity Cancer; Paranasal Sinus and Nasal Cavity Cancer; Paranasal Sinus Cancer |
Clinical Trial: BMS-247550 Plus Cisplatin in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
This study has been completed.
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining BMS-247550 with cisplatin in treating patients who have metastatic or recurrent head and neck cancer.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Hypopharyngeal Cancer Laryngeal Cancer lip and oral cavity cancer Oropharyngeal Cancer paranasal sinus and nasal cavity cancer Salivary Gland Cancer | Drug: BMS-247550 Drug: cisplatin Procedure: chemotherapy | Phase I Phase II |
MedlinePlus related topics: Head and Neck Cancer; Nasal Cancer; Oral Cancer; Salivary Gland Disorders
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I/II Study of BMS-247550 and Cisplatin in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
OBJECTIVES:
- Determine the recommended phase II dose of BMS-247550 when administered with cisplatin in patients with metastatic or recurrent squamous cell carcinoma of the head and neck. (Phase I)
- Determine the toxic effects of this regimen in these patients.
- Determine the response rate, time to progression, and survival of patients treated with this regimen. (Phase II)
- Determine the pharmacokinetics of this regimen in these patients.
- Correlate selected markers from peripheral blood mononuclear cells and tumor samples with toxicity and response in patients treated with this regimen.
OUTLINE: This is an open-label, dose-escalation study of BMS-247550.
- Patients receive BMS-247550 IV over 3 hours and cisplatin IV over 30-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, up to 10 additional patients receive treatment as above at the recommended phase II dose of BMS-247550.
- Phase II: Patients receive treatment as in Phase I at the recommended phase II dose of BMS-247550.
PROJECTED ACCRUAL: Approximately 3-47 patients (20-27 for phase II) will be accrued for this study within 1 year.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the head and neck considered incurable by surgery or radiotherapy
- No nasopharyngeal disease as primary site
- Extensive, local-regional or distant metastatic disease
- Newly diagnosed OR
- Recurrent disease after initial treatment with surgery or radiotherapy (including neoadjuvant chemotherapy or concurrent chemoradiotherapy)
- Measurable disease
- If only site of measurable disease is in a previously irradiated area, disease progression after radiotherapy must be documented
PATIENT CHARACTERISTICS: Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 2.0 mg/dL
- Transaminases no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver involvement)
Renal
- Creatinine no greater than 1.5 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No evidence of active infection
- No other malignancy within the past 2 years except curatively treated stage 0 or I cancer
PRIOR CONCURRENT THERAPY: Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- No prior chemotherapy for recurrent disease
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- At least 6 months since prior radiotherapy and recovered
Surgery
- See Disease Characteristics
- Recovered from prior surgery
Location Information
Pennsylvania
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104-4283, United States
Diane Hershock, MD, PhD, Study Chair, University of Pennsylvania Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: October 2003
Last Updated: October 13, 2004
Record first received: April 7, 2003
ClinicalTrials.gov Identifier: NCT00057850
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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